Jaguar Health (NASDAQ:JAGX) released second-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below.
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Summary
Jaguar Health highlighted a strategic shift towards rare disease gastrointestinal programs, focusing on crofelemer for intestinal failure indications with potential market opportunities up to $8 billion annually by 2033.
The company completed a U.S. commercial out-license agreement with Future Pacific for Mytesi and Canalevia-CA1, receiving $18 million upfront and additional potential milestones totaling $17 million.
Clinical trials for crofelemer showed promising results, with reductions in parenteral support requirements for MVID and SBSIF patients, indicating significant clinical relevance.
Financial metrics showed a decrease in net revenue for prescription products by 60% compared to Q2 2025, while operational losses decreased due to reduced costs from the Future Pacific agreement.
Despite increased net loss attributable to common shareholders, the company emphasized the potential for non-dilutive funding from future partnerships and the perpetual exclusivity of crofelemer under FDA botanical guidance.
Full Transcript
OPERATOR
Good afternoon. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to matters such as continued growth, prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends, and product initiatives, including products in the development stage which may not achieve scientific objectives or meet stringent regulatory requirements.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations, and projections about future events. While management believes its assumptions, expectations, and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements.
The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the Forward-Looking Statements and Risk Factors section of the company's Form 10-K for the year 2025, which was filed with the SEC on April 7, 2026, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar Health's website. Except as required by law, Jaguar Health undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect information, future events, or otherwise.
Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar Health believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss, and are not substitutes for or superior to measures of financial performance in conformity with GAAP.
Today's conference is being recorded. At this time, it is now my pleasure to turn the call over to Lisa Conte, Jaguar Health Founder, President, and Chief Executive Officer. Lisa, the floor is yours.
Lisa Conte, President and CEO
Oh, thank you very much, Paul. Hello, and thank you all for joining our investor webcast today. My name is Lisa Conte. As you heard, I'm the founder, President and CEO of Jaguar Health and our wholly owned subsidiary, Napo Pharmaceuticals. I'm also the Chairman of our Italian subsidiary, Napo Therapeutics. As usual, I may use the words Jaguar and Napo interchangeably when I'm referring to our company. After I speak, our CFO, Carol Lysack, will provide a recap of the financial highlights for the second quarter of 2026.
The theme of today's webcast is Transformation, Near-Term Catalysts, and Sharp Strategic Focus. As many of you who have followed this company may recall, this past January 2026 we completed a transformative transaction: the signing of a U.S. commercial out-license agreement with Future Pacific for Mytesi, the brand name of our FDA-approved tablet formulation of crofelemer for adults living with HIV/AIDS and diarrhea, and for the brand name Canalevia-CA1, our conditionally approved formulation of crofelemer for dogs with chemotherapy-induced diarrhea.
We made the strategic decision to out-license Mytesi to Future Pacific first because they had recently acquired Theratechnologies, an HIV-focused commercial company with more than four times the commercial effort of Jaguar in the U.S., including two other HIV-related and relevant products, and secondly to fulfill our strategic plan to bring in meaningful non-dilutive dollars to help fund our sharp development focus on our pivotal-stage program for our novel proprietary powder-for-oral-solution formulation of crofelemer.
So a different product of crofelemer—same active ingredient, different product, different formulation—for rare intestinal failure indications. Rare meaning we have orphan drug designation for the intestinal failure indications in the United States and Europe. We are now fully a rare disease GI company, with 100% of our human development efforts sharply and strategically focused on a rare disease program. Our ultimate strategy continues to involve identifying a development and commercialization partner for this program.
Just to put this in perspective, the out-license to Future Pacific was $18 million upfront, primarily for the U.S. HIV market, a market with peak annual market opportunity of maybe $50 to $70 million annually. Intestinal failure has an annual peak market opportunity assessed by third parties of approximately $8 billion. To comment for a moment on two recent third-party transactions of interest: in June of 2026, Eli Lilly licensed Hanmi's Phase 2 GLP-2—not GLP-1, not the weight-loss thing—GLP-2, which is for intestinal failure/short bowel syndrome, in fact for the rare disease of short bowel syndrome, in a deal worth up to $1.26 billion, including $75 million upfront and up to $1.185 billion in milestones plus royalties. In August 2026, just a week ago, Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront plus up to $500 million in milestones—a potential $1.32 billion deal—centered on a proof-of-concept clinical-stage KCNT1 inhibitor for an ultra-rare genetic epilepsy remarkably analogous to the program we have going on in intestinal failure. So we are now focused on identifying a potential partner for rare disease indications that have a global market estimated to be in the multi-billions, with analogous deals that have proof of concept that is earlier stage than what we have in hand. The near-term value driver in our intestinal failure development program is our lead target indication, pediatric microvillus inclusion disease—I'm going to refer to that as MVID—an ultra-rare disorder with no approved therapies and a lethal natural history. We've embarked on an ongoing clinical path toward a potential clinical package to be finalized by the end of 2026—so we're talking just a couple of months away—and an NDA submission in mid next year, 2027.
Short bowel syndrome—which you'll hear me refer to as SBS—with intestinal failure (SBSIF) represents a larger follow-on indication, using the same dosage form and physiological mechanism as intestinal failure with MVID patients, still a rare orphan indication. Our intestinal failure program represents a blockbuster global market opportunity in terms of addressing this catastrophic unmet medical need in patients—and blockbuster in terms of beneficial impact to morbidity, mortality, and the cost to the health care system—and in the financial return opportunity for all stakeholders, including of course shareholders.
And this return opportunity is especially important to a potential corporate partner. The global market for short bowel syndrome with intestinal failure is, as I mentioned, estimated to reach approximately $8 billion in 2033, and a different third party estimates the value of the global MVID marketplace—which is an ultra-rare indication—at over $1 billion in 2033, for which there are no treatments and nothing in clinical development other than crofelemer.
So I want to take a moment to describe the catastrophic impact of intestinal failure on patients and their caregiving community, which includes the healthcare professionals, the family members, and others. Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes, and nutrition through IV administration—IV administration for the nutrients of life—which is all encompassed in something called TPN, total parenteral nutrition.
With supplemental intravenous fluids, overall TPN with fluids is called PN, parenteral support—IV support for your nutrients of life. Many intestinal failure patients require parenteral support—IV nutrition—up to 7 days a week and sometimes for 20 hours a day or more. So obviously this is a catastrophic situation. For the patient’s healthcare quality of life, while it is supportive, it's palliative and it is necessary for life sustenance. It's also associated with serious complications, including liver and kidney toxicities. Compromised cognitive function can have negative impact on growth and survival. And the cost is meaningful. It's estimated about $500,000 a year in the United States per patient. But the cost to the healthcare system, with the inevitable complications—if you can imagine being on IV nutrition every single day—so the complications of infections and keeping that balance of the nutrients of life correct, can top over a million dollars per year per patient.
And in addition, the mortality risk. MVID is a congenital disease. So the patient is born and has massive diarrhea and is unable to absorb nutrients of life. Often these patients just die right away. If the patient is not diagnosed immediately, that's what happens. If the patient is diagnosed, they will be on parenteral support for the rest of their life—again, seven days a week, 20 hours a day. The key of what we're looking for in providing adjunctive therapy to these patients is a reduction in the amount of time that they are on parenteral support.
Reducing that parenteral support can have a significant impact on the massive toxicities and comorbidities that are life-shortening for these patients—life-sustaining parenteral support that is life-shortening because of the toxicities associated with it. So the endpoint in the clinical development is the possibility to reduce parenteral support by even 10% to 15%. That, from a quality-of-life perspective, would allow the patient to receive most of their parenteral support at night while sleeping, preserving some quality of life—the ability to go to school during waking hours—and the patient would not need to be attached to an IV to go through some of the normal daily living activities. So remember that number, 10% to 15%. This past June we presented groundbreaking results at the 58th annual European Society for Pediatric Gastroenterology, Hepatology and Nutrition meeting, and it was in Lille, France. We presented at ESPGHAN the results of the liquid oral crofelemer—the formulation specifically for intestinal failure—to demonstrate substantial reductions in PS, and PS in particular, because these are children who are growing, normalized to body weight, in pediatric intestinal failure patients that were dosed orally for more than one year with no significant clinical or laboratory abnormalities. So basically clean, clean safety. In one MVID patient, the weekly parenteral support requirements, normalized to body weight, were reduced by up to 48%—remember the 10% to 15% I mentioned? We're talking about up to 48%—following more than 12 months of crofelemer therapy. In the two SBSIF patients, the PS requirements, normalized to body weight, were reduced by up to 40% again for over a year of treatment. This is a stunning result.
It's hard to express how clinically relevant this is. As I mentioned, even a 10% reduction would have been considered clinically relevant. What was also really powerful is that after these patients were treated for about three months, they were, per protocol, taken off crofelemer and they immediately relapsed and needed to be put back on crofelemer—so one of the strongest trial design parameters to demonstrate the true efficacy of a product. So these patients have now continued to be treated for over a year, and we expect they'll be on crofelemer for the rest of their lives.
And we take great pride in providing the product for that. There have been no crofelemer-related safety issues in our intestinal failure patients or any patient treated with crofelemer, and very consistent with the crofelemer that is in thousands of patients that have been in clinical trials for other disorders. As a reminder, drugs are approved by the FDA on their benefit-risk ratio. When the risk is zero, the benefit exists into perpetuity. Now we have an additional MVID patient in compassionate use being treated with oral crofelemer under an FDA-authorized expanded access program.
And safety and efficacy data regarding this infant was also presented at the same ESPGHAN meeting this June in Lille. And this is a fascinating situation where the patient was diagnosed with MVID right after birth but was too young to enroll in the enrollment criteria imposed by the FDA on Napo's clinical trial. So with the expanded access to crofelemer, the child was able to—at 3 months of age, or a little less—get on to crofelemer. The child is now a year old, thriving, has a very active Instagram site, and is almost at the 30% level in the growth curve.
So in what was otherwise a catastrophic diagnosis with a lethal natural history, this child is thriving. The patient has started to eat a little bit orally and is down from 22 hours of parenteral support to 18 hours—just in the first year of life. So we are committed to providing our novel crofelemer formulation as an investigational drug, as deemed medically necessary by the physician or caregiver, for patients in these expanded access programs intended for mitigating the sequelae from MVID disease progression.
The participation in expanded access programs allows us to develop relationships with this very small community of physicians, institutions, and patients who are addressing intestinal failure—intestinal failure in particular associated with the ultra-rare disease of MVID—before the product is approved and commercially launched. Simultaneously, we are conducting a blinded clinical trial to evaluate the safety and efficacy of this formulation of crofelemer in pediatric patients with intestinal failure due to MVID.
So a blinded trial simultaneously—different than the results that I just spoke to, which are treatment-only and unblinded—and we can see the results. This pivotal randomized, double-blind, placebo-controlled trial is fully enrolled and taking place at clinical trial sites in the United States, Italy, and the UAE. In support of our planned New Drug Application filing based on patients in this trial, we submitted an amendment and received FDA authorization for a treatment-only extension phase of the trial.
So after the blinded part is over, patients can continue in a treatment-only extension if deemed relevant for the patients by a safety committee—of which we are not a member—that remains blinded, as well as the treating physician and the family. Every single patient was deemed relevant to go into the treatment-only extension phase. So the first MVID patients have entered the treatment-only extension, and with the patients from this treatment-only extension, the early patient access patients—the results that were presented, for example, at ESPGHAN—and the investigator-initiated trial in the UAE, we're talking about the opportunity to file for a New Drug Application for crofelemer for MVID, an ultra-rare disease for which we have orphan designation in the United States and Europe, with essentially a single-digit number of patients, including the patients in our blinded trial and the MVID patients in the expanded access and investigator-initiated trials. We estimate that we're treating approximately 4% of the patient population. So while it may sound bold that we're filing with a single-digit number of patients, it's relevant to other diseases given the percentage of the affected patients that we are treating.
We are confident, and we're passionate, to bring the benefit of crofelemer to approval for all MVID patients as expeditiously as possible. So regarding timeframe, we're looking to complete enough patients in the treatment-only extension from the blinded trial—as I mentioned, all the patients from the placebo-controlled part of the trial qualify to go into the treatment-only—so enough patients by the fourth quarter this year to file for Breakthrough Therapy designation in the United States.
With Breakthrough Therapy designation, if it's granted, this would give us the opportunity for a review upon filing the New Drug Application of perhaps just four months after we file the NDA. The clinical package to file the NDA is expected to be ready by the end of 2026, with the actual submission of the NDA in the second quarter—late in the second quarter—of 2027. So with Breakthrough designation, we could be approved in the U.S. by the end of 2027 for MVID.
Europe would be a bit later—that would be in 2028—based on European Medicines Agency and some of the reimbursement as well as risk-benefit analysis. Intestinal failure in MVID is the same situation as intestinal failure in short bowel syndrome. Short bowel syndrome patients with intestinal failure—they're unable to absorb the nutrients of life because they literally have a short bowel; there's not enough surface area. A normal intestine is about 20 to 25 feet, and an SBSIF intestine may be 5 feet or less.
So there's literally just not enough surface area, and they too may end up on parenteral support up to 20 hours a day, seven days a week. And they have the same comorbidities, the same horrendous toxicities that you see with parenteral support in MVID patients. We have ongoing right now a Phase 2 randomized, double-blind, placebo-controlled trial with the same formulation—the liquid formulation of crofelemer—in adult SBSIF patients, and it's going on at various sites in Germany and Italy.
This is still an orphan indication, and we do have orphan designation in the U.S. and Europe for short bowel syndrome, just as we do for MVID in the U.S. and Europe, though it is a larger patient population than MVID, which arises from congenital abnormalities. SBS could be congenital abnormalities; surgical resection due to conditions like Crohn's disease, ischemia; surgical resection due to cancer, which is about a third of the patients; trauma; accidents. Adult and pediatric SBSIF patients face chronic dependence on parenteral support due again to their insufficient absorptive surface area in the intestines. In the United States the population is about 12,500. We're targeting the NDA filing of crofelemer for MVID in mid-2027, and we expect this NDA filing to be coincident with the timing of the availability of results from the Phase 2 blinded study for SBS. Because our development program for MVID involves the same formulation, this plan provides CMC—chemistry, manufacturing, and controls—basically the manufacturing stepping stone to our planned pathway for ultimate approval of crofelemer for SBS after MVID. And it will be years after MVID. But the safety would be the same. The manufacturing would be the same. So in the competition world, there's nothing for MVID—there's nothing out there in development, there's nothing for these patients. In SBS there is a product approved, and it's a GLP-2 approach—not GLP-1, that's the weight-loss thing. GLP-2 is essentially a growth hormone, and what GLP-2 does is attempt to grow the intestine a bit so that parenteral support can be reduced by 10% to 15%.
If you remember, those numbers are what's considered clinically relevant. Again, we blew those away with the 40% to 45% in MVID. GLP-2—growth hormone—for SBS is not standard of care. There are many side effects, and it's a growth hormone; you can't use a growth hormone—for example, you don't want to encourage growth in cancer patients or anybody with a hyperproliferative abnormal situation—and that is about a third of the SBS patients. But nevertheless, what GLP-2 has done is established a business model and a regulatory approval benchmark.
GLP-2s are reimbursed at about a half a million dollars a year per patient in the United States. We are seeking to have crofelemer become the standard of care for intestinal failure in both MVID and SBS. GLP-2s are only used in about 5% to 7% of patients. They can't be used on a lifelong chronic basis, whereas crofelemer could. Crofelemer could even be used in conjunction with GLP-2s. So crofelemer is really a paradigm-shifting opportunity to increase quality of life, potentially extend patients' life, and have important physiological benefits and reduction of potential toxicities.
So what I've been talking about in our rare disease program—intestinal failure program—is crofelemer. Crofelemer is the active ingredient in Mytesi, but our intestinal failure program is not Mytesi. It is a different formulation, a different product. Mytesi is a pill. With intestinal failure, a pill would just go right through the patient—high throughput, high transit times—it would land in the toilet bowl. The oral liquid formulation—a highly concentrated lyophilized formulation of crofelemer—is non–growth hormone, and it's a drug candidate that would be used as adjunctive therapy to parenteral support through a first-in-class physiological mechanism of action, reducing liquid stool output and therefore reducing parenteral support needs and the associated toxicity associated with that. It's also important to note that crofelemer is defined as an antisecretory—first-in-class—drug. It's not an antidiarrheal. It's locally acting on intestinal chloride ion channel, and normalization reduces intestinal chloride-driven fluid accumulation, and so—we're getting a bit technical here—but it results in reduction of the electrolyte and the fluid losses and the concordant parenteral support reductions, which is the clinically relevant endpoint in both MVID and short bowel syndrome intestinal failure. We established our ability to perform and close an important non-dilutive business development deal in January with the Future Pacific deal. As I mentioned, we were provided $16 million non-dilutive capital in January upon closing of the agreement. We satisfied some specific post-closing conditions and received an additional non-dilutive $2 million, which was part of the upfront fee from Future Pacific. We continue to be the manufacturer of crofelemer for Mytesi and the Canalevia formulations for Future Pacific, and per the terms of the opportunity—and that is at a profit.
So it's a profit center for us. We are a centralized manufacturer, and per the terms of the agreement we have an opportunity to receive up to another $17 million in additional milestone payments—future payments—again non-dilutive. The intestinal failure market that we are now sharply focused on is considered to be approximately 100 times larger than the HIV diarrhea market. So with those numbers that I told you—basically $18 million upfront, $17 million additional milestones—we're talking about a market opportunity 100 times larger.
With the clinical proof-of-concept data we have in hand and the very near-term clinical and regulatory milestones ongoing, we are confident in our ability to execute our business development goals in our intestinal failure program to further the opportunity to bring in serious, meaningful, valuable non-dilutive dollars commensurate with the market size, the serious unmet medical need, and driven first and foremost by the benefit—and the benefit-risk, with risk being nearly zero—that we are providing to the patients with no alternative treatment.
Just briefly, I should mention the major focus of our business is human health, of course, and our rare disease program is 100% of our human focus. We do have a small business in animal health, and we're pleased to announce recently that we're planning for the anticipated commercial launch very, very shortly of a product called Neonorm Dog. It's a new extension of Jaguar's non-prescription Neonorm franchise for companion animals. Neonorm Dog is designed to provide dog owners with access to a plant-based, non-prescription product intended to support normal stool consistency and GI fluid balance in dogs.
It's also an antisecretory mechanism of action, and what we're doing is leveraging the relationships that we built when we were conducting the promotion and the education around Canalevia-CA1 before it was licensed to Future Pacific. Canalevia-CA1, again, was our FDA conditionally approved prescription drug for the treatment of chemotherapy-induced diarrhea in dogs. The Neonorm franchise currently includes other Neonorm non-prescription products for foals and for calves—plant-based products to support proper hydration and bowel health in pre-weaned foals and calves.
Many of the vets that we spoke with when we were educating and promoting around chemotherapy-induced diarrhea indicated a strong unmet need for addressing general watery diarrhea in dogs of any cause. And now, with Neonorm Dog, we will have something to offer them and to the dog parents, with easy availability of Neonorm Dog through online and animal health retail channels, not just from their vet, including Amazon and Chewy, which is an absolutely fantastic place for animal health products.
So with that description, you can hear that we're very excited, very enthused about what we're doing, and I'm going to hand the discussion over to Carol Lysack, our CFO, for her recap of the financial highlights of the second quarter of 2026. And just before I turn it over, to remind everybody that for many years we were selling Mytesi ultimately into the distributors and had a sales force promoting directly to the physicians who are prescribing to patients.
At this point, we are supplying to Future Pacific, and so there's a much different impact on the sales and the revenue numbers that we are reporting. Carol, let me turn it over to you.
Carol Lizak, Chief Financial Officer
Good afternoon, Lisa, and thank you to all of you who have joined our webcast today. I'll begin my review of our financials for the second quarter of 2026. License and grant revenue: As Lisa mentioned, Jaguar Health entered a U.S. commercial licensing agreement with Future Pak in January 2026, and Future Pak is now the exclusive U.S. marketer for the company's Mytesi and Canalevia-CA1 products. License revenues for the initial $16 million upfront payment, in addition to the $3 million payment for early termination of the buyback option under this agreement, were recognized by the company in the first quarter of 2026.
As announced in August 2026, Jaguar Health has satisfied the closing conditions required to receive payment of the non-dilutive $2 million holdback amount of the upfront fee from Future Pak. Napo remains the manufacturer of crofelemer and Mytesi and supplies the product to Future Pak at cost-plus terms. Additionally, the company recognized license fees of $43,000 in the second quarter of 2026 from a securities purchase agreement with a European partner, which was supported by a binding term sheet.
Approximately $43,000 of license fees were consistently recognized in each of the quarters of 2025 under this agreement. As of June 30, 2026, the total deferred revenue associated with this contract amounts to $468,000. Federal grant revenue recognized in the second quarter of 2026 for the clinical trial study related to the treatment of chemotherapy-induced diarrhea, or CID, in dogs was $25,520, and none last year. For prescription product revenue, net, the total net revenue for the company's prescription products — that's Mytesi, Gelclair, and Canalevia-CA1 — was approximately $1.2 million in the second quarter of 2026, which was comprised primarily of sales of Mytesi at cost-plus to Future Pak. In January 2026, Jaguar Health entered into a royalty-free license agreement with Future Pak. Again, under this agreement, all revenues generated in the United States from Mytesi and Canalevia-CA1, effective from January 12, 2026, are directed to Future Pak. Future Pak is privately held and does not report Mytesi sales. Compared to the second quarter of 2025, the number of Mytesi bottles the company sold in the second quarter of 2026 increased significantly, and commercial costs were substantially decreased.
The decision to enter a commercial license agreement with Future Pak aligns with Jaguar Health's strategic focus on advancing the development of its powder-for-oral-solution formulation of crofelemer for rare disease indications related to intestinal failure in humans. The total net revenue for the company's prescription products in the second quarter of 2026 represents a decrease of approximately 2% compared to the first quarter of 2026, when total net revenue for prescription products was approximately $1.2 million.
Additionally, prescription products net revenue decreased by 60% compared to the second quarter of 2025, when total revenues amounted to about $2.9 million. The loss from operations decreased, however, by about $400,000, going from a loss of $8.0 million in the quarter ended June 30, 2025 to a loss of $7.6 million in the quarter ended June 30, 2026. This change was primarily due to a $1.7 million decrease in product net revenue, but was offset by a reduction in operating expenses of approximately $2.1 million, largely attributed to the Future Pak licensing agreement.
For non-GAAP recurring EBITDA, the second quarters of 2026 and 2025 were a net loss of about $8.4 million and $7.9 million, respectively. Net loss attributable to common shareholders increased by approximately $2.3 million, from a loss of $10.4 million in the quarter ended June 30, 2025 to a loss of $12.7 million in the quarter ended June 30, 2026. In addition to the loss from operations, interest expense increased by $176,000, from $15,000 interest income for the quarter ended June 30, 2025 to about $161,000 in the quarter ended June 30, 2026, due to interest expenses accrued on notes.
The fair value of financial and hybrid instruments designated as FVO, or fair value option, increased by about $900,000, from a loss of $1.1 million in the quarter ended June 30, 2025 to a loss of $1.9 million in the quarter ended June 30, 2026, and again primarily due to fair value adjustments in liability-classified warrants and notes payable designated as FVO. Loss on extinguishment of debt increased by $1.7 million, from a loss of $1.8 million in the quarter ended June 30, 2025 to a loss of $3.5 million during the three months ended June 30, 2026, due to significant modifications that qualify for extinguishment accounting, with none recorded in the same period in 2025. Well, that concludes my recap of high-level financials for the second quarter of 2026. I will now hand the discussion back to Lisa. Thank you.
Lisa Conte, President and CEO
Thanks, Carol. We'll wrap this up quickly. As a recap, our intestinal failure program will continue to provide clinical proof-of-concept milestones and is the subject of ongoing business development discussions with the potential to bring in meaningful non-dilutive dollars from potential licensee partners. Importantly, crofelemer's status as the first and only oral prescription drug approved by the FDA under botanical guidance functions as a de facto and perpetual IP intestinal protection shield, exclusivity shield, as there is no practical pathway to bring a generic to market.
So even though we have a very robust and expensive IP patent strategy, just like any other pharmaceutical company — the price of being in the business — we do have approximately 185 issued patents. We essentially have exclusivity perpetually, to infinity and beyond, which is very powerful when doing terminal value calculations with, for example, potential commercial partners. You don't have that patent cliff that you often hear about and read about with other companies.
So as you can probably tell, all members of the Jaguar, Napo, and Napo Therapeutics family are fully engaged, fully energized, and excited about the multiple near-term expected catalysts on the regulatory and clinical side for crofelemer and on the business side, all of which we view as significant, extremely value-enhancing, and potentially transformative for patients and for diseases with completely unmet medical needs. Everything we do at Jaguar, Napo, and Napo Therapeutics is rewarding, and our efforts to address such truly devastating, rare intestinal failure diseases has really provided satisfaction on another level.
This concludes our webcast for today. Thank you very much for joining, and we'll see you next quarter.
OPERATOR
This concludes today's conference. We thank you again for your participation. You may disconnect your lines at this time.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice.
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